Clinical Toxcicology · 510(k) · 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.. Cleared by FDA on 27 October 2005 under submission K043341, product code NVI (diagnostic software, k-nearest neighbor algorithm, autoimmune disease). What FDA's record says, in FDA's words.
Device record · K043341
- Device. BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMDEVICE
- Company. BIO-RAD LABORATORIES, INC.COMPANY
- Decision. 27 October 2005, 510(k), substantially equivalent (traditional review); received 3 December 2004DECISION
- Panel. Clinical ToxcicologyPANEL
- Product code. NVI, Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune DiseaseCODE
- Regulation. 21 CFR 862.3100, Class IIREG
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code NVI. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
13 March 2019 · Injury · SURPASS 5X20 · STRYKER NEUROVASCULAR CORK · report 3008881809-2019-00071
IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS AFTER THE PROCEDURE FOR THE ANEURYSM AT THE RIGHT INTERNAL CAROTID, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED A NON-OPTIMAL POSITION OF THE FUSIFORM ANEURYSM COMPONENT OF THE INTERNAL CAROTID ARTERY (ICA) AFTER DISSECTION, PROVIDED BY THE FLOW DIVERTER. THEN APPROXIMATELY 2 MONTHS LATER, A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE FLOW DIVERTER WAS PERFORMED SEVERAL TIMES TO TREAT THE DISSECTION ANEURYSM. GOOD DILATION RESULT SHOWED IN […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NVI, in Clinical Toxcicology, or cleared in 2005. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.